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Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia

NCT03724838 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-01-10

No results posted yet for this study

Summary

Previous studies have shown that expectant management of preeclampsia in the context of extreme prematurity may improve perinatal outcomes. Indeed, it has been estimated that for each additional day of pregnancy prolongation between 24 and 32 weeks of gestation, there is a nonlinear corresponding gain of 1% in fetal survival. In this study, we evaluate the use of Esomeprazole alone or with Sildenafil Citrate for the treatment of singleton pregnancies complicated by preeclampsia. We hypothesized that the potential increase in uteroplacental and fetoplacental blood flow with the use of Esomeprazole alone or with Sildenafil Citrate may be associated with pregnancy prolongation (the primary study outcome) and improved maternal and perinatal outcomes.

Conditions

Interventions

DRUG

Esomeprazole with Sildenafil Citrate

Patients will take esomeprazole single dose of 40 mg orally once a day

DRUG

Sildenafil Citrate

Patients will take Sildenafil Citrate 40mg every 8 hours

DRUG

Placebo to Esomeprazole

Patients will take inert tablets similar in appearance, color, and consistency to esomeprazole single dose of 40 mg orally once a day

DRUG

Placebo to Sildenafil Citrate

Patients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours

Sponsors & Collaborators

  • Aswan University Hospital

    lead OTHER

Principal Investigators

  • hany f sallam, md · Aswan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2021-11-30
Completion
2022-01-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03724838 on ClinicalTrials.gov